BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3791802 · Received January 6, 2014

    Report

    Report Number
    1720753-2014-00129
    Event Type
    Malfunction
    Date Received
    January 6, 2014
    Date of Event
    December 15, 2013
    Report Date
    January 6, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. REPAIR INFO WAS DOCUMENTED IN A DIFFERENT SERVICE RECORD. NO CONCLUSION CAN BE DRAWN AS CONCLUSIVE REPAIR INFO IS UNAVAILABLE AT THIS TIME AND NO ADD'L SERVICE INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM INTERMITTENTLY FAILED TO ALLOW FLUOROSCOPIC EXPOSURES AND EXHIBITED INTERMITTENT FUNCTIONALITY. NO PT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8262 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1